Component: Facilities
- Verify compounding area meets level A
requirements.
- Area is clean, orderly, and good state of repair
- Storage area is appropriate
- Space for compounding is adequate
- Frequency
- Every six months or
- Equipment is installed, repaired
- Contamination problem is identified
Component: Equipment
- Refrigerator temperature verification
- Verify logs monthly, more often if issue is identified
- Calibrate temperature probe every 6 month using the Slush test
- Verify Balance calibration
- Balance calibration to be done every six months
- Documentation
- /Dropbox/Akron/Documentation/Equipment Calibration Log.doc
- Slush test
- Fill a polystyrene or plastic cup two-thirds full with cold water. Place the cup in the freezer until a fine layer of ice forms on top and a small section of ice forms within the fluid (about 2 hours). If ice is present, this ensures that the mixture is at 0°C (+32°F).
- Place the temperature probe in the middle of the cup (do not touch the sides or bottom).
- Observe the temperature after 2 minutes. The temperature should drop to 0°C (+32°F) within 2 minute
- Most thermometers are calibrated to be accurate to ±1°C or better. If the temperature reading is more than 1°C (+34°F) above or below 0°C (+32°F) at 2 minutes, replace the battery and test again. If the thermometer is still not within range, contact thermometer manufacturer for instructions regarding recalibration procedures or replace the thermometer.
- If the calibrated thermometer indicates an out-of-range temperature and if it is properly positioned, assume that it is accurate and take immediate steps to safeguard the vaccine. Once the vaccine has been safely stored under proper conditions, the accuracy (and batteries) of the thermometer can be checked. However, always check other causes of inappropriate storage temperatures first.
Component: Personnel
- Verify compounding personnel
skill/training
- Completion of the Skill Assessment found on the Akron SOP website (Home › Compounding › Staff Skills Assessment)
- Frequency
- When new compounding personnel are hired or returning from extended leave
- Yearly to ensure compliance with policy and procedures
- If necessary for investigating incidences, accidents, or contamination is identified
Component: Final Preparation
- Master Formulation Records
- Verify yearly or when new information becomes available
- Final Product
- Verify final product matches prescription.
- Verify protocols have been followed.
- Verify ingredients are verified
- Verify final product assessed for clarity/color, odor and consistency.
- Verify labelling and container are
correct.
- Method: Review of documentation every 6 months.
- Documentation
- Verify documentation of procedures
- Verify necessary initials/signing are completed
- Verify entries are completed in logs
- Review documentations every 6 months.
Component: Documentation
- Policy and Procedure
- Verify up to date every 3 years
- Compounding records
- Verify records are meet regulatory requirements every 6 months
- Safety Data Sheets
- Verify availability yearly